Compact Urinary Catheter With Pre-Attached Collection Bag
Urinary catheter assemblies (10) with pre-attached urine collection containers (14) are disclosed, The urine collection container is spaced from the catheter tube (12) by a connector (16, 16′, 16″) to allow for easier manipulation of the catheter tube without interference of the collection container.
This application claims the benefit of and priority to U.S. Provisional Application No. 62/409,115, filed Oct. 17, 2016.
FIELD OF THE DISCLOSUREThe present disclosure is directed to urinary catheters with pre-attached urine collection containers. The present disclosure is further directed to a compact, intermittent urinary catheter that is easy to manipulate, particularly by a user with limited dexterity, without interference from the pre-attached container. The present disclosure is also directed to a compact, intermittent urinary catheter connected to and spaced from a pre-attached urine collection container by a flexible connector.
BACKGROUNDCatheters are used to treat many different types of medical conditions and typically include an elongated catheter tube that is inserted into and through a passageway or lumen of the body. Urinary catheters and, in particular, intermittent urinary catheters are commonly used by individuals who suffer from certain abnormalities of the urinary system, such as urinary incontinence. With the advent of intermittent urinary catheters, individuals with problems associated with the urinary system can conveniently self-catheterize to drain the individual's bladder. Individuals who suffer from urinary incontinence will often self-catheterize several times a day.
Self-catheterization involves removing the catheter assembly from its package and inserting and advancing the catheter tube through the user's urethra. Often, urinary catheter assemblies include a urine collection container or bag that must either be attached by the user or is pre-attached to the catheter. In many cases, users of intermittent urinary catheters have limited or diminished dexterity that is often the result of spinal cord injuries. Catheter assemblies with attached urine collection containers may be particularly difficult to manipulate by individuals of limited dexterity as the container is often in close proximity to the catheter and may interfere with the user's ability to comfortably position the catheter or advance the catheter.
Thus, for these and other reasons, it is desirable that the intermittent catheters and the urine collection containers associated therewith be easy to manipulate and deploy. To that end, it would be desirable to space the pre-attached container away from the catheter tube such that it does not interfere with self-catheterization and helps promote urine flow into the container, and yet is not spaced so far from the catheter that the user must deal with excess tubing and excess material, making the assembly less compact and more cumbersome to manipulate.
SUMMARYIn one aspect, the present disclosure is directed to a urinary catheter assembly that includes a catheter tube having a proximal end and a distal end. The catheter tube defines a flow path and includes one or more access eyelets at its proximal end. The catheter assembly also includes a urine collection container defining an interior urine collection chamber wherein the container is spaced from the catheter tube by a bendable or otherwise deformable connector. The connector includes a first end and a second end, and defines a flow path between the catheter tube and the collection chamber.
In other aspects, the catheter assembly may include a flow indicator that determines the presence of liquid and/or the rate of liquid flow within the flexible connector or the catheter assembly flow path.
The bendable connector may be, without limitation, a separate polymeric tube with a smooth finish connected to a distal end of the catheter, a flat sheet and/or an extendible and pleated member located between the catheter tube and collection container.
With reference to the Figures,
Spacing container 14 at a distance from the catheter also allows container 14 to be positioned vertically lower than catheter 12, which aids in the flow of urine into container 12 during catheterization (due to the declivity). As container 14 fills and becomes heavier and more difficult to grasp, the flexibility of connector 16 allows container 14 to be placed a selected distance from catheter, making the catheterization process less cumbersome by not having to keep container 14 close to catheter 12.
Accordingly, connector 16 should be of sufficient length to allow for adequate spacing of catheter tube 12 from container 14 and allow independent movement of catheter tube 12 relative to container 14. In that regard, connector 16 should not be so long that it includes excess tubing as one would typically encounter with catheter assemblies employing a “leg bag”. In accordance with the present disclosure, connector 16 should be of sufficient length to allow for easy manipulation of catheter tube 12 without interference from collection container 14. Container 14 should be freely movable with movement of connector 16. An example of a suitable connector 16 length is, for example approximately 5 to approximately 10 cm.
As shown in the Figures and discussed below, connector 16 may preferably be an elongated, separate member that is attached to the catheter tube and the container, respectively. In another embodiment, discussed in connection with
Flexible connector 16 defines flow path 19 (
As further shown, catheter assembly 10 may include a gripping member 20. Gripping member 20 (which may also serve as a funnel) provides a flow conduit for the urine during self-catheterization. As seen in
In one embodiment, connector 16 may be joined to gripping member 20 by providing a port (not shown) that may be attached to gripper 20, by spin welding, as generally described in U.S. Application Publication No. 2015/0105756, which is incorporated by reference. Other bonding techniques, such as solvent bonding, may also be used to attach proximal end of connector 16 to open end 15 of gripping member 20. For example, in one embodiment, connector 16 may be attached to gripping member 20 (and ultimately catheter 12) by an attachment fixture 30 as shown, for example,
Continuing with the description of fixture 30, proximal and/or distal end 32, 34 may each respectively, include barbs 36 and 38. Barbs 36 and/or 38 may typically be provided as integral portions of fixture proximal and distal ends 32, 34 of fixture 30 and have greater outer diameter(s) than adjacent portions of the respective proximal/distal ends 32, 34. As shown in
As discussed above, connector 16 may be joined to container 14 either directly (as generally depicted in
Connector 16, shown in
The catheter assembly described herein where catheter tube 12 (with gripper 20) connector 16 and collection container are all pre-attached, prior to use, provides a closed urine catheterization and collection apparatus. In an alternative embodiment, collection container 14 and connector 16 may be fully integrated with the connector being attached (e.g., press fit using a barb) to gripper 20 by the user just prior to catheterization.
Where visual detection of flow is desired, connector 16 may be sufficiently transparent and/or sufficiently flat. For example, in the embodiment of
Other forms of visual detection of fluid flow may also serve to indicate the presence of flow. For example, flow indicator 26 may be provided with a gauge, a needle, a spinning paddle wheel, plastic spheres that move or spin or the like, in response to flow.
In addition to the above, an electro/mechanical flow indicator 26 (generically depicted in
In addition, flow indicator 26 may not only monitor the presence and flow of fluid, but may also analyze the composition of the urine for purposes of monitoring bladder health and/or compliance with treatments, therapy, or rehabilitation protocols. Flow indicator 26 may allow for wireless digital connection, which can provide alerts on mobile devices and the like.
Turning now to
It should be understood that various changes and modifications to the embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the invention disclosed herein.
Claims
1. A urinary catheter assembly comprising:
- a) a catheter tube having a proximal end and a distal end, said catheter tube defining a flow path and including one or more access eyelets at said proximal end;
- b) a urine collection container spaced from said catheter tube by a deformable connector, said urine collection container comprising a urine collection chamber; and
- c) said connector comprising a first end and a second end, wherein said flexible connector defines a flow path between said catheter tube and said chamber.
2. The urinary catheter assembly of claim 1 wherein said connector comprises a flexible polymeric tube.
3. The urinary catheter assembly of claim 1 wherein the connector comprises a compressible and extendable connector.
4. The urinary catheter assembly of claim 1 wherein said connector is bendable 180° without kinking.
5. The urinary catheter assembly of claim 1 wherein said flexible connector comprises an outer wall defining said flow path.
6. The urinary catheter assembly of claim 3 wherein said outer wall is pleated.
7. The urinary catheter assembly of claim 1 further comprising a flow indicator.
8. The urinary catheter assembly of claim 7 wherein said flow indicator is configured to detect urine within the flow path of said flexible connector.
9. The urinary catheter assembly of claim 7 wherein said flow indicator is configured to detect the rate of flow through said flexible connector.
10. The urinary catheter assembly of claim 1 further comprising a gripping member.
11. The urinary catheter of claim 1 wherein said connector comprises an attachment fixture.
12. The urinary catheter assembly of claim 10 wherein said gripping member comprises a funnel.
13. The urinary catheter assembly of claim 10 wherein said first end of said connector is solvent bonded to said gripping member.
14. The urinary catheter assembly of claim 10 wherein said first end of said connector is attached to said gripping member by an interference-type fit.
15. The urinary catheter assembly of claim 11 wherein said gripping member or said connector comprises one or more barbs.
16. The urinary catheter assembly of claim 1 further comprising a connection port on said urine collection container configured for attachment to a distal end of said flexible connector.
17. The urinary catheter assembly of claim 16 wherein said second end of connector comprises a connection port configured for connection to said connection port of said collection container.
18. The urinary catheter assembly of claim 1 wherein said connector is made of a polymeric material.
19. The urinary catheter assembly of claim 1 wherein said catheter tube has a stiffness, and said connector has a stiffness that is different from said catheter tube.
20. The urinary catheter of claim 1 wherein said connector comprises a shaft with a central axis wherein said connector is configured for movement in three dimensions relative to said central axis.
Type: Application
Filed: Oct 17, 2017
Publication Date: Oct 24, 2019
Inventors: Martin McMenamin (Lifford), Paul C. Fletter (Mount Prospect, IL), Adam J. Foley (Sword, IL)
Application Number: 16/341,853